The Pfizer / Bioentech Kovid-19 vaccine is “safe” and “well tolerated” in children 5 to 11 years of age and the right dose induces a “strong” immune response, according to the results of a study released by laboratories Monday.
The two companies plan to submit this data to authorities “as soon as possible,” according to a statement.
These are the first clinical data at this age. The European Medicines Agency (EMA) and the US FDA have authorized Pfizer / BioMtech and Modernna vaccines based on messenger RNA technology since the age of 12.
Pfizer CEO Albert Bourla commented that “since July, pediatric cases of COVID-19 in the United States have increased by 240%, highlighting the need for vaccination, especially due to the prevalence of the delta variant.” “Strong basis for authorization requests”.
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The side effects of the vaccine, usually by injection of 30 micrograms at a dose of 10 micrograms, are usually “comparable” in older, 16- to 25-year-olds, both labs note.
These are partial results of a study of 4,500 children aged 6 months to 11 years in the United States, Finland, Poland and Spain.
Both companies expect to publish results from the “fourth quarter” at the age of 2-5 years and 6 months -2 years after receiving two injections of 3 micrograms.
Studies on children under 12 years of age for the Modernna vaccine are ongoing.
In Israel, children between the ages of 5 and 11 are at risk of serious complications from COVID-19, having been vaccinated since August 1st. It is a “special authorization” without waiting for clinical data, and each injection is “studied on a case-by-case basis,” the Ministry of Health said.